Fluid management system for arthroscopic surgery

ABSTRACT

An improved fluid management system for irrigation of a body cavity and in particular for use in arthroscopic surgery having a pressurized fluid circuit for supplying irrigation fluid and a vacuum fluid circuit for withdrawing waste fluid from the cavity. In a preferred embodiment there is an uninterrupted fluid supply comprised of a plurality of sterile solution saline bags with an automatic spiker to perforate the bags. The system is processor controlled with numerous safety and design features to automate arthroscopy to the highest degree possible. Some of the features include the monitoring and tracking of cavity pressure and flow rates to predetermined pressure and flow rates, tracking cavity to mean blood pressure, overpressure protection, a plurality of pressure and flow rate baseline settings, monitoring, setting and controlling saline supply, and specialized functions for providing pressure and flow rates for typical surgical procedures such as lavage, clear view, and burr/shaver. One or more vacuum discharge lines may be provided with an automatic self-cleaning feature. The system is compact and optionally employs a number of disposable components, including a novel fluid accumulator. In one preferred embodiment there is a compact gravity irrigation fluid management apparatus employing automatic pressure regulating means. An improved console for monitoring out-of-fluid anomalous conditions is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part application based on patentapplication Ser. No. 08/683,745, filed Jul. 17, 1996.

FIELD OF THE INVENTION

The present invention generally relates to endoscopic procedures whichrequire a fluid medium, and more particularly with arthroscopic surgery.

BACKGROUND OF THE INVENTION

Arthroscopic surgery is a minimally invasive therapeutic and/ordiagnostic procedure, during which small sized visualization andsurgical tools are introduced into a joint body cavity (most commonly aknee) through very small incisions. Typically, at least three incisionsare employed for a therapeutic procedure and at least two for adiagnostic procedure. During the surgery, irrigation of the joint isnecessary for the following reasons:

(1) Distention of the joint is desirable for better visualization andaccess achieved by an increased joint or tissue separation. This isaccomplished by application of pressure through the medium of theirrigation fluid to the tissue structure and causes closing of the bloodvessels;

(2) Flow of the irrigation fluid through the joint keeps the field ofview clear and often evacuates most of the loose debris;

(3) The fluid keeps the joint lubricated and replaces lost body fluids.

There are thus two independent factors at work here, the pressure andthe flow rate of the irrigation fluid. The function and need forindependent control of these two factors can be illustrated by thefollowing situations:

(a) There are times during the surgical procedure when one needs to viewand reach the far or posterior end of the joint. The joint separationneeds to be increased without any need for an increased flow. A higherpressure in the joint will achieve this.

(b) If there is debris or bleeding in the joint, a quick flush of fluidis needed to clear the field of view. Such conditions require a higherfluid flow rate and with slightly higher pressure, assuming the jointseparation is adequate.

(c) When an accessory instrument is used, like a shaver with wallsuction, a higher fluid inflow is required to keep up with the increaseddemand and prevent the joint from collapsing. A higher flow rate but thesame set pressure is needed here. Traditionally, the typical solution isto use sterile fluid bags hung above the level of the patient which areconnected to the joint by a tube. The bags are raised to obtain morepressure and the flow rate is controlled by using variable clamps on thetubing leading to and away from the patient. The control for the twooperations is manual and decided upon by the surgeon.

Furthermore, when burring and shaving large amounts of debris forms andcan quickly block the exit port leading from the body cavity.

Thus there is a continuing need to improve automated pressure regulatingsystems and other systems used in arthroscopic or other fluid relatedprocedures in order to provide for automated handling of various aspectsof the procedure which the surgeon or supporting staff would otherwiseneed to handle manually.

There is further a need during arthroscopic surgery--which can last froma few minutes to several hours--to change saline bags. Up to a dozen ormore saline bags may be required in an operation, and during a manualspiking of the bag, when infusing saline solution from the bag to thebody cavity being operated on, air may be accidentally introduced intothe fluid tube leading to the body cavity and may interfere withvisualization, and saline solution may be spilled. Saline bags may alsorun dry unless medical personnel attend to the bags. In addition, oftenthe number of bags needed to complete the operation is not estimatedproperly. Furthermore, in gravity fed pressurized saline infusions ofthe type described above, the pressure inside the tube leading to thebody cavity can only be varied by raising or lowering the saline bag,which limits the range of pressure achievable and is not accurate.

BACKGROUND INFORMATION

U.S. Pat. No. 4,650,462 (the "462 patent" to DeSatnick et al.) disclosesan irrigation system for use in arthroscopic surgery that employspressure feedback to control pressure and flow rates. However, thesuction in the '462 patent is due solely to atmosphere from a syphoneffect, and there is no provision for providing a greater thanatmosphere vacuum. Furthermore, the '462 patent does not supplypressurized fluid in the inflow line greater than the gravity head fromthe supply of saline solution, that is, the pressurized supply fluid islimited by the height of the saline bag rack, which is in turn islimited by the height of an average nurse and the ceiling height of theoperating theater. In addition, the pressure feedback control system ofthe '462 patent, though a closed loop, tends to react passively tochanges in body cavity pressure, to vary the outflow valve closing rateand the speed of the inflow line pump, in a lagging manner, with noability to actively predict changes in pressure and/or flow rate.Rather, the control system hunts and seeks to find the optimal flow rateand pressures in a passive, mechanical manner once an imbalance in jointcavity pressure is detected. As a consequence, the system described inthe '462 patent seems to be prone to relatively wide swings in actualflowrate and pressure about the desired parameters that is disconcertingto surgeons. Furthermore, there is no provision in the '462 patent forthe automatic, uninterrupted supply of saline solution throughout anoperation.

The present invention offers an improved design to the irrigation devicefound in the '462 patent by incorporating, among other features, a highvacuum (greater than from atmosphere alone) suction from the body cavitybeing irrigated, improved operation of the flow control using aplurality of valves downstream of the body cavity, a more accuratepressure transducer, a pressurized inflow line that does not dependsolely on the gravity head, a spiking mechanism for saline bags for thecontinuous flow of fluid from the saline bags with a plurality ofbuilt-in safety features, and a microprocessor controlled feedbackoperation that is not passive but, using software, can actively predictand anticipate changes in flowrate and/or pressure to achieve smoothertracking of pressure and flow rates.

In conventional arthroscopic or fluid dependent systems, pressure issensed in the surgical cavity with either a relatively large diameterdedicated cannula or is incorporated into an inflow or outflow cannula.Liquid/air separation is accomplished with a diaphragm immediatelyadjacent to the operating site. Some disadvantages of such conventionalcavity pressure sensing systems are that: a) the pressure sense line andliquid/air chamber adds bulk to the irrigation fluid supply line and arecumbersome to handle; and b) the elastic forces from the liquid/airdiaphragm either introduce errors in pressure readings or system has tobe calibrated to obtain accurate pressure data. The pressure sensingsystem of the present invention is an improvement over this prior art.

SUMMARY OF THE INVENTION

The invention, which in one preferred embodiment is called the AC2000Fluid Management System or AquaCenter 2000 (AC2000), is a complete,self-contained, portable fluid management system for use in arthroscopicsurgical procedures or any other fluid dependent surgical irrigationprocedure. The major features of the portable, self-contained fluidmanagement system include a self-contained and automatic fluid supplysystem comprising a sterile solution supply cabinet that allows for anadequate supply of sterile solution bags for completing mostarthroscopic or other fluid related procedures in an automated manner;an automatic fluid delivery and control system including a pump andinflow tubing connected to a cannula or scope; an automatic fluidretrieval system including tubing from an outflow cannula or scope and acavity pressure control valve, and including tubing from a motorizedshaver or other vacuum related instruments with a liquid sensor andcontrol valve for providing for the flow requirements of a motorizedshaver or other vacuum related instruments; a cavity pressure sensingand control system which maintains cavity pressure at a desired level; adisposable tubing system comprising an inflow line, pressure sense line,pressure compensation line, patient outflow line, motorized shaveroutflow line, floor waste retrieval line, and drape fluid retrievalline; a self-contained waste collection system including a wastereceiver cart with capacity for an adequate quantity of waste receivercanisters to complete most arthroscopic or other fluid relatedprocedures, and a vacuum system, driven independently of the fluid drivepump, for driving the fluid retrieval system and floor and drape vacuumpickup.

More specifically, the present invention includes the followingfeatures:

1. Automatically sequencing and spiking of sterile solution bags asneeded to provide an uninterrupted supply of fluid throughout the case.

2. Means for sensing of pressure in the surgical cavity.

3. Means for setting desired cavity pressure manually or automaticallyin relationship to the patient's blood pressure.

4. Ability to set flow and pressure independently of each other.

5. Controller for maintaining set cavity pressure.

6. Out of Tolerance Flow Controller for adjusting from set flow ratewhen required to maintain set cavity pressure.

7. A liquid sensor and controller to automatically provide for the flowneeds of most any motorized shaver and/or other vacuum relatedinstruments.

8. Auto-sequenced and manual functions displayed on a console includinglavage, clear view, prime, drain, burr, pause/run, alarm silence, poweron/off, and a surgical diagnostic mode which provides means for settingpressure for distention of surgical cavity with no egress cannula.

9. A help mode (message center) on a console to help users set up or toidentify malfunctions.

Accordingly, it is one object of the present invention to provide anautomated fluid delivery system for the continuous supply of fluid to abody cavity from a plurality of sterile bags (or containers), with theminimum amount of human intervention, and without having to interrupt anoperation to change bags. The present invention further employs safetyfeatures to indicate when flow is cut off, when flow is resumed, andsensors and check valves for overpressure, for pressure sensing withinthe body cavity, and for suction backflow.

Thus in one preferred embodiment of the present invention for use inarthroscopy, there is provided in an apparatus (the AquaCenter 2000,AC2000) for storing saline bags and providing total fluid management inarthroscopy. The apparatus has a user-input console, and a door openingto a series of elevated and inclined racks. Each rack holds up to threesaline bags, chained together in series. All the bags lead to an inflowmanifold where a safety device (a flow-interrupt/air sensor valve) ispresent. From the manifold a positive displacement peristaltic pumppumps the saline fluid to a removable cartridge accumulator, wherebubbles are removed and surges are attenuated. Thereupon, in response toan improved pressure transducer sensing pressure inside the body cavity,to user input as to the type of operation being performed and fromsoftware, a processor controls pump speed and/or one or more exit valvesto vary the degree of pressure and/or flow rate inside the body cavitybeing irrigated. Downstream of the body cavity, and workingindependently from the compressor driving the positive displacementpump, is a vacuum compressor that keeps a vacuum tank at high vacuum(potentially much greater than atmosphere) which can be used both withparticular surgical tools and in connection with an exit tube leadingfrom the body cavity to suck waste fluid and debris from the bodycavity. A waste trap is employed to filter out solid waste from thewaste fluid slurry.

In another aspect of the present invention, there is provided animproved pneumatically driven linear actuator spiking assembly employinga spiker needle/trocar to drive a normally withdrawn saline infusion bagspike into the saline bag. An arming switch on the apparatus acts as asafety.

In yet another aspect of the present invention there is disclosed animproved pressure transducer that employs a novel design to makepressure readings inside a body cavity more accurate.

In a further aspect of the present invention there is provided anautomatic body cavity pressure tracking feature that automaticallyvaries cavity pressure according to the patient s mean blood pressure.

BRIEF DESCRIPTION OF THE DRAWINGS:

FIG. 1 is a schematic of the operation of the principal components usedin the present invention.

FIG. 2 is a perspective view of one preferred embodiment of the cabinethousing assembly of the present invention.

FIG. 3 shows one preferred embodiment of the spiker assembly of thepresent invention:

FIG. 3a shows a top plan view of the saline bag spiker assembly;

FIG. 3b shows a side cross sectional view;

FIG. 3c and 3d show the spiker perforating a saline bag; and

FIGS. 3e and 3f show top cross-sectional views of the piston and pistonhousing of the spiker assembly.

FIG. 4 shows a perspective view of the flow interrupt sensor manifold ofthe present invention.

FIGS. 5a-c show one preferred embodiment of the removable accumulatorcartridge of the present invention:

FIG. 5a shows the front of the accumulator;

FIG. 5b shows the back view of the accumulator; and

FIG. 5c shows the side view of the accumulator.

FIG. 6 is a front view of the console used in a preferred embodiment ofthe present invention.

FIG. 7 is a schematic of the improved cavity pressure sensing system ofthe present invention.

FIG. 8 is a perspective view of another embodiment of the presentinvention.

FIG. 9 is a schematic of another embodiment of the present invention.

FIG. 10 is a schematic of a device to be used with the embodiment of thepresent invention as depicted in the configuration of FIG. 9.

FIGS. 11A and 11B depict another embodiment of the present invention,having an automatic pressurizing means employing a gravity feed.

DETAILED OF THE PREFERRED EMBODIMENTS

Turning attention to FIGS. 1 and 2 there is shown the overallconfiguration of the apparatus of the fluid management system, which ina preferred embodiment is termed the AquaCenter 2000 (AC2000). It shouldbe understood by one skilled in the art that while in the preferredembodiment the supply of irrigation fluid is a sterile fluid such assaline solution, the present invention may be used to supply anuninterrupted supply of any body fluid to a body cavity, including thesupply of blood, blood plasma or medicated fluids.

The AC2000 fluid management apparatus is processor controlled, byprocessor 10, with user input from console 12 and/or a hand held remotecontrol 14. The AC2000 has a housing 15, which contains a cabinet forstorage of sterile solution supply, shown as a plurality of saline bags20. The fluid management system is shown in FIG. 1 as having apressurized fluid supply circuit 17 and vacuum assisted waste dischargefluid circuit 17. The AC2000 compactly houses both the pressurizedconduit fluid circuit and vacuum conduit fluid circuit, which areseparate fluid circuits as indicated by dashed lines 17 and 17' in FIG.1, in a compact manner side by side in housing 15. Thus in a preferredembodiment of the AC2000 both the vacuum system and the pressurizedsupply system are compactly housed in the same housing 15, as indicatedby FIG. 2, with the supply fluid and discharge conduits spaced compactlytogether.

In FIG. 2 each shelf of the housing 15 contains up to three bagsconnected serially to one another through their automatic spikerassemblies, but a fewer or greater number of bags or containers andcorresponding spikers may be used. The bags are kept sealed in a sterilecondition until needed, and connected to cabinet shelf supply conduits22 at each rack level, which link together the spiker assemblies, whichform a auto-spiker tubing set assembly. The saline bags are spiked witha saline bag spiker assembly allowing fluid to flow along the cabinetsupply conduits 22 to a manifold 35 in an uninterrupted manner, withoutthe necessity of changing bags during an operation. The manifold 35 isplugged into a flow interrupt safety switch 51, as described herein. Theconduits 22 of the supply cabinet are pressurized, typically at somepressure value greater than atmosphere, and are closed to atmosphere(though safety vents may in incorporated into the conduits in the eventof overpressure). From the manifold 35 fluid is driven by and throughthe pressurized fluid supply pump 40, which may be any kind of pump butpreferably a positive displacement pump of the peristaltic kind to avoidfluid contamination by the pump. The saline supply fluid is pumped by aplurality of rollers of peristaltic pump 40 (as shown in FIG. 5a asrollers 40'), working on the flexible tubing against a roller guidetrack (not shown), which slides open to allow one to withdraw theflexible tubing 42, which leads to and wraps around the peristaltic pumprollers, and is optionally preferably disposable. Saline fluid is drivenfrom the inlet of the peristaltic pump assembly into the inlet of aremovable cartridge accumulator 46, which is removable and preferablydisposable. Also optionally disposable but reusable upon sterilizationis the flexible tubing connected to the cartridge accumulator leading tothe patient (supply conduit 48), as well as the discharge tubing (wastefluid return conduits 68, 69) leading from the patient.

Cartridge accumulator 46 serves a variety of purposes, such as allowingany air bubbles trapped in the fluid supply conduits to escape from thesaline fluid solution, acting as a surge suppressor, and acting as apressurized reservoir for the irrigation fluid. The accumulator isclosed to atmosphere but has a plurality of escape valves on its backside that vent to atmosphere, as the accumulator can be pressurized atpressures greater than atmosphere to deliver saline solution atpressures greater than conventional gravitational head.

Pressurized irrigation fluid traveling downstream of the cartridgeaccumulator 46 travels through the patient inflow supply line 48,through a trocar, cannula, Luer fitting, surgical tool or other suitabledevice attached to the supply line at the incision site 50, and intobody cavity 52 (indicated as by dashed lines in FIGS. 1 and 2). Apressure transducer sense line 54 is parallel and in communication withthe irrigation fluid supply line 48 and the pressure inside body cavity52, as described more fully below, and together with the pressuresensing system 56, allows the processor that controls the overall systemto make accurate readings of the static pressure inside the knee withrespect to atmosphere and the pressure in the fluid supply line 48.Another pressure transducer 56 may sense the pressure inside the supplyline 48 and signal the processor. Thereon, based on the sensed pressuredata and in response to user input the processor may change the speed ofthe drive pump 40 and/or the flow rate through the exit valves 60, 62downstream of the body cavity 52 that control the flow through thedischarge conduits 68, 69, to alter the rate of flow into and passingthrough the body cavity and/or the pressure inside the knee. Thesoftware in processor 10 is designed to track preselected desiredpressure and flowrates in response to measured and derived pressures andflowrates in an automatic manner.

Downstream of the body cavity 52 are two exit valves, 60 and 62, eachcontrolling the flow through vacuum assisted waste fluid return conduits68, 69, respectively. The waste fluid return conduits 68, 69 are eachconnected to body cavity outflow cannula ports at incision sites at thebody cavity 52. The valves and waste fluid discharge conduits are partof a hard vacuum fluid discharge system connected to a vacuum tank 70and serviced by a vacuum compressor pump 72. Valve 60, the outflowactuator "R-valve", controls the flow through patient outflow returnline 68 (one of two discharge fluid conduits), which ordinarily carriesthe bulk of the waste fluid from the body cavity. Valve 62, theshaver/suction instrument actuator "T-valve", controls the flow in theshaver suction line 69 (the second of the two fluid discharge conduits),which is usually used during shaving and burring operations during thearthroscopy. The R and T valves may be connected with a Y-tee (as shownin FIGS. 1 and 2 downstream of the body cavity) to a single vacuum linethat leads to a waste receptacle, such as canister 73 in FIG. 1, a twopart waste receptacle manufactured by Baxter Healthcare, part nos.64-B38B and 23-2307C. Additional vacuum conduits and receptacles may beprovided as need be, such as floor vacuum pickup 74, or a drape suctionline at the patient. An optional fluid sensor such as liquid sensor 75may be connected in-line to one or more of the lines, to indicate to theprocessor that liquid is still flowing through the line and exiting thebody cavity 52.

Vacuum pump 72 periodically keeps vacuum tank 70 at a certainpredetermined vacuum pressure, which is typically greater than thesiphon effect created by atmosphere acting alone. In this way a vacuummay be formed that is independent of gravitational effects and does notdepend on syphoning. Thus the vacuum fluid discharge system of theAC2000 more readily sucks out debris and waste fluid from the bodycavity. A plurality of suitably placed check valves maintain the fluiddischarge conduits in vacuum and prevent backflow. A filter 78 may beemployed for the exhaust of vacuum compressor pump 72 to preventcontamination by any airborne waste debris. The plurality of wastereceptacle canisters such as 73 and 80 are preferably disposable. Thewaste receptacles 73, 80 are attached to the housing for a portable,self-contained design.

Software driven processor 10 communicates with and controls all themajor components of the AC2000 through I/O lines and interface andcontrol circuitry, known per se in the art. All major components of thesystem communicate with the processor, which preferably is amicroprocessor (μP). Thus both the peristaltic pump motor 40 and vacuumpump 72 communicate with the processor 10 through control lines.Numerous other components of the system also communicate with theprocessor via suitable control lines, such as the fluid interrupt sensor15 in flow interrupt manifold 35, spiker assemblies 30, cavity pressuresensing system 56, pressure transducer 56', R-valve and T-valves 60, 62,a blood pressure monitor, fixed console 12, hand held remote console 14,water level sensors in fluid cartridge accumulator 46, and optional flowsensors 75.

To avoid potential overpressure of the supply conduit 48, an optionalbypass valve may be present in the fluid supply conduit upstream of thebody cavity and may act as a safety valve in the event of overpressureand/or notify the processor in the event of overpressure.

Furthermore, to aid in diagnostic procedures, there may be providedbypass ports just upstream and just downstream of the body cavity 52, onthe supply and discharge lines, to allow fluid to bypass the body cavitywhen the two supply and discharge lines are connected through the bypassports.

In addition, during certain procedures involving the shaving and burringof human tissue, the T-valve 62 of the waste discharge vacuum conduit 69is "burped" or randomly or selectively opened and closed automaticallyfrom a closed state to a wide open state for a predetermined shortperiod of time by the processor in order to help prevent theaccumulation of waste debris in the shaver suction line. The R-valve 60of the vacuum discharge conduit 68 may also be "burped" by theprocessor. Typically "burping" occurs every 15 seconds and upon anyoverpressure situation (e.g. where the cavity pressure exceeds a setpressure). Burping may also be used to reduce body cavity pressure inthe event an overpressure is detected.

A fixed console 12 is used as the main display and control panel toinput data into the processor and receive information relating to thestatus of the system, such as pressure readings, type of medicaloperation to be performed (e.g., lavage, drain, burr, clear view),system operations (e.g., priming the pump, pause, run, autopressure,increasing cavity pressure and/or flow rates). A portable hand heldremote console is also provided with some of the same features as thefixed console for use by the surgeon performing the arthroscopy.

Though the preferred embodiment of the invention is for use inperforming arthroscopic surgery with saline fluid, other fluids may beemployed in the present invention to perform other surgical operations,without departing from the scope of the present invention.

Turning attention to FIGS. 2 and 3 regarding the overall operation ofachieving an uninterrupted supply of saline irrigation fluid, there isshown a perspective view of the AC2000 in one preferred embodiment ofthe fluid management system a housing 15, with a cabinet, having a fourshelf trays 90, each of which has three bays, which are concave,inclined at an angle to the horizontal, and receive saline bags 20. Thebags are made of the flexible plastic material, with a outflow portnozzle 95 that receives the saline bag spiker, as shown in FIG. 3b.While in a preferred embodiment the bags are flexible and hold 3000 mlof saline fluid, other size bags and different types of containers,including rigid containers, may be employed.

The housing 15 of the AC2000 is mounted on wheels or coasters with aplurality of handles for maximum mobility and a swinging door (notshown) covering the front. The unit is portable, and stands 60" incheshigh and weighs approximately 180 lbs. when fully loaded. Console 12gives the user information and perform vital functions as describedfurther herein.

Optionally disposable, but reusable, flexible tubing 22 leads from thespiker assembly 30 of the saline bags to the fluid interrupt sensingmanifold 35. The spiker assembly, as described further herein, isconstructed so flexible tubing 22 remains closed to atmosphere, and thespiker needle trocar is ordinarily withdrawn into a spiker housingassembly when not inserted into a saline bag, thus preventing salinefluid from leaking and atmosphere from being introduced.

Two sets of tubing are found on the AC2000, an outer set and inner set.The outer set is designed to be detachable from the AC2000 andordinarily be disposable (the preferred U.S. practice) but may besterilized and reused. The outer tubing set comprises the patient inflowline 48, the pressure sense line 54, a pressure compensating line forthe pressure transducer, as shown in FIG. 7 and as further describedherein, at least one patient outflow line, such as line 68 (as best seenin FIG. 1), which is connected to vacuum, an optional second vacuumoutflow line for a shaver or other vacuum related instrument, such asline 69, a floor waste retrieval line 74 (as seen in FIG. 2), a drapefluid retrieval line (not shown) and other optional lines leading to thepatient. These lines are bundled for convenience as one would commonlydo in electrical wiring for convenient handling. One advantage ofproviding for shaver flow requirements with the AC2000 tubing set is thereduction of tubing packages required for surgeries.

The inner tube set, which may also be disposable (as per U.S. medicalpractice) but can be reused, consists of the tubing leading from thesaline bags to the spiker device, the tubing 22 interconnecting adjacentspikers and leading to the manifold 35, the inflow line 42 leading fromthe manifold 35 to the peristaltic pump and around the head to thecartridge accumulator 46.

Because of the different tubing sizes available for different bundles,each packaged tube set may be equipped with an identifying means such asa barcode or a magnetic strip which communicates to the AC2000 processorthe particular type of procedure for which the packaged tubeset isintended to be used. Once the particular type of procedure is known tothe AC2000, it may then automatically initialize its various subsystemsto accommodate the particular procedure identified. The tube set containadditional tubing beyond the tubing contained in conventionalarthroscopic or fluid related systems.

Turning attention now to FIG. 3, there is shown the spiker assembly ofthe AC2000. FIG. 3a shows a top view of a shelf with the left hand sidecut away to expose the piston cylinder 140 that drives the spiker 30,the middle view is of the slots 31 in the shelf that hold the spikerassembly, which is snap fit in, while the right hand side of FIG. 3ashows a top view of a spiker assembly 30 engaging a saline bag 20. Asshown in FIG. 3b-3f, a retractable and protractile hollow piston 110 hasa plunger 115 with at its tip a trocar or hollow needle spiker 120, andis housed in a slidable but fluid tight manner in the cylindricalhousing chamber 124. O-rings 117, 122 provide a fluid tight seal betweenthe hollow piston and the outside, so that air and contaminants are notintroduced into the system during the changing of the saline bag whenthe piston is retracted and during operation when the piston isprotracted.

The housing chamber 124 is detachably fixed at its base to the cabinetin a snap-fit manner, as can be seen by examining FIGS. 3b and 3c inreference to the slots 31 in FIG. 3a. A safety arming switch (not shown)may be triggered to notify the processor when the spiker assembly is inplace so that the driving pneumatic cylinder 140 of the piston plunger115 of piston 110 may be armed to fire. The housing chamber 124 hasfluid ports 126 on each side of it, which when aligned withcorresponding ports 128 on the piston plunger 115 allow fluidcommunication with the spiker bag contents and the AC2000, and allow theautomatic spiker stations (the spikers at each bag) to communicate withone another and downstream with the manifold 35 via shelf conduit tubing22 which interconnects serially the spiker stations.

As shown in FIGS. 3b-3d, actuation of the trocar spiker is through alinear actuator such as a pneumatic cylinder 140 which receives at itsrod end 150 the vertical projection 152 that is fixed to the pistonplunger 115, and fits through a slot in the shelf of the housing. Whenthe pneumatic cylinder is actuated in response to a signal from theprocessor the piston retracts and moves the plunger 115 forward throughits housing 124 and extends the trocar tip 120 past the housing tipportion 160, which is engaged with the saline bag tubing, causing thetrocar tip to pierce the sterile membrane of the saline bag. A safetylatch (not shown) may be set to act as a stop to keep the pneumaticcylinder from retracting, and the safety may be disarmed by theprocessor to arm the spiker. Fluid begins to flow through the trocar andthe hollow piston plunger, then through the side ports and into thecabinet supply conduits.

Although in a preferred embodiment the saline bags are spikedsequentially by the AC2000. As can be seen by inspection the sequentialfiring should be done in an orderly manner from left to right startingwith spiking the bag furthest from the manifold 35 so that the closureof one spiker station to flow when a saline bag is exhausted does notblock the other adjacent bags. Though in a preferred embodiment thespiking of saline bags is sequential, it is within the scope of thepresent invention that two or more bags may be simultaneously spiked ifso desired, in a similar orderly manner.

Turning attention now to FIG. 4, there is shown the flow interruptsafety manifold used in the fluid management system. The manifold 35allows fluid communication between each shelf level of the supplycabinet, to allow them serial access between spiker stations on eachshelf and parallel access between shelves. Thus intake ports 23 ofhollow cylindrical manifold 35 each receive a portion of shelf tubing 22from each shelf (four in the preferred embodiment shown in FIGS. 1 and2), while outflow port 41 feeds into the supply tubing 42 that leads tothe pump 40. Manifold 35 acts as a tiny reservoir of irrigation fluid,holding about 25-30 ml of fluid. When manifold 35 runs dry, it signalsto the processor that the saline bag(s) feeding into the manifold hasbeen spent (or flow has been interrupted) and another bag(s) needs to bespiked. The signal indicating that the manifold is dry is generated byflow interrupt/ air sensing fluid sensor 51, that communicates with theinterior of manifold 35 through a port in the manifold that snaps intothe sensor. The sensor 52 has two prongs 53 and 55, which, whensubmerged in fluid, conduct electricity and remain a closed circuit, butwhen they are exposed to air, become an open circuit. A signalindicating an open circuit is then generated and related to theprocessor.

As an alternative to or in conjunction with the sensor in the flowinterrupt manifold 35, other means of indicating when the saline bagshave run out of fluid, such as counting the revolutions of theperistaltic pump 40 and estimating the fluid displaced, or employingadditional sensors, may be used in the present invention.

Turning attention now to FIGS. 5a-c, there is shown the removablecartridge accumulator 46 of the AC2000. As best shown in FIG. 5a, thecartridge receives the part of the patient inflow supply line 42 at itstop end 172 that proceeds to wrap around the peristaltic pump 40, andreturns to empty into the port 174 of the cartridge 46 and into thereservoir 176 of the cartridge to form a fluid reservoir having a fluidlevel 178. Thereupon any bubbles present settle or escape out of thesaline solution, the pressure surge from the peristaltic pump isattenuated, and a reservoir of saline fluid is formed between twominimum and maximum fluid levels. As shown sterile saline irrigationfluid exits the accumulator into supply line 48. The minimum and maximumfluid levels permitted are demarcated by two fluid level sensors 182,184, that sense the maximum and minimum fluid levels. The sensors are ofthe same two prong open circuit/ close circuit type as found in the flowinterrupt manifold 35, where two prongs, when submerged in fluid (whenfluid level 178 covers them), conduct electricity and remain a closedcircuit (indicating fluid is present between the prongs), but when theprongs are exposed to air, become an open circuit. In this way theprocessor knows when the reservoir is nearing its capacity or when thereservoir is running dry. By receiving signals from these sensors theprocessor can tell whether the fluid level has reached the minimum ormaximum recommended levels.

As shown in FIGS. 5b and 5c, at the back of the cartridge accumulatorand inside the cartridge accumulator (making the entire unit optionallydisposable) are received portions of two flexible tubes from the suctionlines 68 and 69 of the patient outflow line and the shaver suction line,respectively. Compactness is achieved in the cartridge accumulator byhaving the two tube portions pass through into the cartridge accumulatorand be joined at a Y-connection as shown, to drain via vacuum line 73'to waste canister 73. The vacuum discharge conduits 68, 69 are pinchedby the R-valve and T-valve pinch valve actuators 60, 62 acting throughwindows 210 and 212 in the cartridge accumulator, to close the flowthrough the flexible tubes. In this way the R-valves and T-valves closethe vacuum discharge conduits in the preferred embodiment, when it isdesired to restrict the flow and/or change the pressure in the bodycavity. The R-valve and T-valve actuators may be a ON/OFF type pinchactuator that either fully pinch close or are fully open, or theactuators may be variably opening and closing actuators to allow partialand variable flow through the suction line R and T valves when thevalves are actuated. Suitable signals would be present from both valvesto and from the processor to indicate their state and to regulate them.Processor controlled pinch valves may also be employed on the inflowline 42 or any other conduit. Other valve assemblies may be employed torestrict inflow or outflow without departing from the scope of thepresent invention.

The air in pressurized fluid accumulator 46 is vented to atmospherethrough filtered vent port valves 220, shown in FIG. 5b.

Turning attention now to FIG. 6, there is shown the front console usedin a preferred embodiment of AC2000 fluid management system. The console12 employs a touch membrane pad for input and a LED diodes for visualdisplay. A plurality of status lights 300 are shown on the left handside of the console, one for each spiker station bag, to indicate whichsaline bags have been spiked, as the bags are spiked sequentially in thepreferred embodiment. A plurality of buttons are used to communicate tothe processor which operation or function is to be performed. There arebuttons 302 and 304 for increasing or decreasing target flow rate andcavity pressure manually to a certain predetermined baseline level,which the processor will then automatically attempt to maintain. Otherbuttons provide for certain common predetermined surgical proceduressuch as "drain"311, "lavage" 312, "clear view" 313, "burr" and "shaver"314 (upper and lower half of button 314). A more detailed description ofthese features is provided herein. In addition, an automatic pressuretracking button 319 is provided for the feature where the processor ofthe AC2000 will vary the pressure and flow rate into the body cavity totrack the mean blood pressure of the patient, which typically variesgenerally periodically, as measured from a blood pressure monitor inputtransducer (not shown) that inputs data into the processor 10.

Further input button functions are provided on the touch pad for primingthe pump to relieve the system of air and initialize it at "prime"button 316, a "pause" button 317 (lower half of button) for suspendingand maintaining present system parameters, a "run" button 317 (upperhalf) for resuming flow.

Other buttons such as buttons 360 may be employed for arming the spikerassembly, for providing a "menu" button 320 for step by stepinstructions for set up and operation (which may be displayed in the LEDinteractive display 330), a demo or tutorial button for simulatedprocedures, an alarm silence button 340 for silencing any alarmspeakers, a scroll button 341 scrolling through the interactive display330, a backlight button 342 for lighting in the AC2000, such as in thespiker cabinet, a power button for powering the AC2000 and othersuitable buttons for other features of the apparatus as taught herein.

Status lights are also present in console 12 for indicating variousstates of the AC2000. A body cavity pressure gauge with a bar graphoutput 375 indicates actual and/or desired cavity pressure in anypreselected units, such as ft. of water or mm-Hg (with a typical rangefor pressure and vacuum inside the body cavity of between 0-150 mm-Hg).Display windows 370 shows selected pressure baseline settings, whilewindows 380 show actual pressures by the pressure sensing system of thepresent invention. Other status lights can indicate whether there is anoverpressure (such as when the waste canisters are full or the tubing iskinked); whether flow rate is set for "max.", "high", "mid" or "low"flow rates (typically the set flow range for the AC2000 is between0-2000 ml/min); whether bags need to be reloaded; which auto spikerstation (bag) is being spiked and drained, whether there is a blockage,out of fluid, overpressure or other malfunction, and other functions ofinterest. The LED display 330 may output text for the operator of theapparatus. A printer port may be provided for printing data. Alarms andother audiovisual displays may be provided for certain procedures andstates of the AC2000.

Turning attention now to FIG. 7, there is shown the improved cavitypressure sensing system 56 of the present invention. The AC2000 deviceeffectively senses pressure in the surgical cavity using a differentialpressure transducer and novel fluid circuits. Pressure is sensed in thesurgical cavity 52 through a small diameter needle in-line with senseline 54 (e.g. an 18 gauge needle). A small diameter (e.g., approx. 0.050inch I.D.) pressure sense line 54 and compensating line 720 (transducervent drip line) are liquid-filled to eliminate pressure reading errors.Both the pressure sense line and the transducer vent line haveair-filled portions connected to the transducer above liquid/airinterface 710 (at line portions 715). The liquid/air interface 710 maybe in the form of a spiral coil tubing set in the horizontal plane at710 (perpendicular to the plane of the paper) that spirals about avertical line parallel to line portion 715. Both lines 54, 710 aresufficient in length and configuration to assure that the liquid/airinterfaces are at the same elevation to eliminate pressure readingerrors. Fluid in the pressure sensing system comes from the irrigationfluid under pressure from the supply line 48 through the flowrestrictors R1 and R2, and fluid in sense line 54, which connects to thesurgical cavity. A compensating drip line 720 ordinarily bleeds slightlyto ensure no air bubbles are trapped in the sense line 54 and parallelsthe sense line.

When pressure is sensed in body cavity 52, the pressure is transmittedby the fluid through the sense line 54 through a filter (not shown) tothe pressure transducer 740 located on the machine housing 15. Adifferential pressure transducer 740 is used to measure the pressure ofliquid in a cavity. A standard off the shelf A/D pressure transducer maybe employed for the differential pressure transducer 740, such as soldby Motorola, part no. MPX-700DP. The head change due to any relativechange of height of the sense spinal needle to the transducer iscompensated by the second line on a reference pressure side of thepressure transducer, drip line 720, as can be seen in FIG. 7. This line,the drip (or compensating) line 720 further may bleed out any airtrapped by dripping out a minute quantity of fluid. The "sense" line 54and "compensating" drip line 720 are preferably of the same length, andboth physically attached near the cavity. Fluid under pressure thatfeeds the body cavity, sense line and drip line comes from the supplypressure line 48. The fluid from this source passes through restrictorsR1 and R2, which restrict the fluid flow to a very low level foraccurate pressure measurement. In this manner, the two sense lines aremaintained full of the sterile fluid (purged of air) to provide anaccurate transmittal of pressure from the patient cavity and tocompensate for fluid head differences within the pressure sense system,between the cavity and the AC2000 transducer.

The compensating line is attached to the sense line to measure the headloss or gain in the compensating line. Since the head loss or gain inboth the sense line and the compensating line are identical and arephysically subtracted by the differential pressure transducer, thetransducer's electrical output will be a measure of only the pressurewithin the cavity, regardless of the difference in liquid head heightbetween the cavity and the remote transducer.

The equation for the electrical output of the transducer is as follows:

    Pc+(P2-Pa)=P1 and P1-P2=Pc-Pa, since Pa=atmospheric=0, then Pc=P1-P2

Since the transducer has some gain (K), then its electrical output isproportional to:

Volts out=K(P1-P2)=proportional to cavity pressure, Pc.

As explained herein, the output of the transducer 740 is supplied to acontrol system governed by processor 10 to regulate and control thepressure and liquid flow to the body cavity 52.

Another advantage of such a cavity sensing system, in addition to thehead compensating feature, is that positive liquid flow may bemaintained into the cavity during pressure sensing, which precludes theentrance of gas (or air) that could modify apparent liquid bulk modulusor provide bubbles that might cause two-state flow, water hammer orslugging in the control system.

Some additional advantages of the pressure sensing system of the AC2000are: (a) the insertion of the slender pressure sensor (spinal needle)into the cavity does not necessarily require an incision and thus doesnot leave a scar; and (b) that, because of their configuration, thepressure sense lines are smaller and less cumbersome, and thereforeeasier for a physician to handle compared to that of conventionalpressure sensing lines.

In another modification of the pressure sensing system, the compensatingline may be eliminated while the overall fluid circuit remains the same.The head loss or gain that is present in the sense line may be zeroedout by the computer through software that estimates the head loss orgain and allows for that factor when computing pressure.

Turning attention now to FIG. 8, though in a preferred embodiment of thepresent invention, as shown in FIG. 2, the saline containers areflexible bags that are supported in bays of shelf trays of a cabinethousing, it is envisioned that a traditional upright configuration maybe employed, so that the one or more flexible bags may be verticallyhung from a rack in a carousel manner. This embodiment is shown in FIG.8. In FIG. 8 the post 818 fits in a telescoping manner over post 817,allowing the carousel rack 819 to rotate, and allowing the ends of bags810 to touch the spikers 830, which are otherwise the same as thespikers 30 shown in the other embodiments. Thus the bags 810 may stillbe spiked by spikers 830 in this configuration (with the spikerspointing upwards) and the irrigation fluid from the bags may then bepressurized by the system using a positive displacement pump as before;or, in the alternative, the pressurized system may be dispensed with andtraditional gravity feed techniques may be employed with the spikers.Bags may be separated from one another by dividers 821 as shown.Furthermore, while a plurality of flexible bags are shown in the FIG. 8embodiment, they may be replaced with one or more rigid and/or largercontainers.

The advantage with the embodiment of FIG. 8 is that certain hospitalpersonnel are more comfortable dealing with saline bags mounted in thetraditional upright manner. Further the FIG. 8 embodiment is moreportable and weighs less, about 60 lbs., than the AC2000 of FIG. 2. Thedisplay console (not shown) and other major components may be similar tothe embodiment described and shown in the FIG. 2 embodiment.

Turning attention now to the embodiment of FIG. 9, there is shownanother fluid management system of the present invention, which isprocessor based and otherwise operates the same as the FIG. 2embodiment. A plurality of fluid bags 920, which may be larger than theaverage saline bag of the FIG. 2 embodiment, have their contents pumpedby peristaltic pump 940 into a 3 liter accumulator reservoir 946,suspended above the patient on a IV pole 947, which has a weight sensor947' built into it so that when the weight of fluid in the accumulator946 drops below a certain predetermined threshold, the processor knowsthat the saline fluid bags need to be replenished. The accumulator 946is pressurized and vents to atmosphere through a filtered vent 949. Asbefore, a supply conduit 948 feeds from the accumulator into thepatient. In another embodiment of the invention of FIG. 9, theaccumulator is not pressurized. Pressure is produced through the gravityhead associated with the accumulator being raised a certain height fromthe floor. In this embodiment the height of the accumulator, asdetermined by IV pole 947, and thus the pressure head, may be changedeither manually or electro-mechanically, as is known per se in the IVpole art. A control panel and extension for this embodiment ofaccumulator is shown in FIG. 10.

Thus, turning attention to FIG. 10, there is shown a control devicedesignated control unit 1001, that is designed to be used with theupright embodiment of FIG. 9, when the accumulator 946 is preferably notpressurized, though a pressurized accumulator could be used as well. Inthis configuration, a post 1003 is set to be clamped from and offset toan I.V. pole 1005, through a series of screw clamps 1006. The unit 1001in turn is attached to an I.V. pole through clamps 1008. Patient inflowline 1021 would supply saline solution to the body cavity. The unit 1001has a cantilevered boom arm 1010 with a weight sensor 1012 to measurethe weight of a saline bag reservoir 946 that hangs from thecantilevered arm. A processor and associated circuitry would monitor theweight of the bag so that if a certain predetermined weight leveldropped below a certain threshold, the processor would instruct theperistaltic pump 940 to pump fluid into the reservoir 946 throughreservoir supply port 1020 and associated tubing, until such time thatthe weight sensor 1012 indicated a satisfactory amount of saline fluidwas present in reservoir 946. At that point the pump 940 would beinstructed by the processor to stop. At the initiation of pumping by theperistaltic pump 940 in response to a signal coming from weight sensor1012, a count-down timing circuit (not shown), which may be a hardwaretimer or software that is driven by the processor, would begin to countdown from a predetermined time. If the pump were to stop pumping beforethe count-down weight sensor 1012 that the saline reservoir 946 is full,the count-down timer would be reset to the predetermined time. If,however, the count-down timer were to reach zero (run out of time) whilethe pump was still pumping or powered on, it would indicate an anomalouscondition that most likely means there is no fluid left in fluid bags920. At this point an alarm may be sounded, a status light 1030 on theconsole of the unit 1001 may be lit, and the pump may be powered off.The unit 1001 may have its own power supply 1040 and a built in powerswitch 1045 for powering on the unit, as well as a start/stop switch1050 for running the unit. Other status lights 1060 for indicating whenthere is a electrical misconnection may also be present.

Turning attention now to FIGS. 11A and 11B, there is shown anotherembodiment of the present invention, having an unpressurized reservoir1101 that is suspended above the operating theater by a height "h", in amore traditional fashion. This configuration of hanging is favored bysome health care professionals due to its familiarity and other factors.A cart 1105 having wheels 1107 and folding or telescoping arms 1109,which collapse to inside the cart when not in use, holds the reservoir1101 of saline solution above the operating theater. Reservoir 1101 isnot sealed from atmosphere and depends on a gravity head to supplypressure to a patient downstream of the reservoir. The gravity head ofpressure "h" ft-water is produced when reservoir 1101 is raised by aheight "h" above the operating table, as shown. This height is regulatedthrough the operation of raising and lowering the reservoir 1101 so thatthe height "h" varies to give varying pressures, which in the preferredembodiment of FIGS. 11A and 11B is achieved through a cable and pulleyarrangement powered by a winch. Cable 1112 is attached to reservoir 1101at the top thereof and runs through pulley 1114, located at the topportion of the apparatus, to a winch 1116 which winds and unwinds thecable in response to a motor 1118 to vary the height "h" of thereservoir with respect to the patient. The height "h" may be controlledautomatically, through processor based control means controlling theoperation of winch 1116, by sensing cavity pressure in a patient's knee,such as with a pressure transducer as disclosed herein or with otherpressure sensing means, to give the proper gravity head to achieve agiven cavity pressure. In the alternative, the height "h" may also becontrolled manually through an operator controlling the powering ofwinch 1116 through switch means, which may be remote from the apparatus1105. Further, the control means may be activated through voiceactivated means controlled by software. Furthermore, the cable 1112 mayhave in-line fastening means 1120 to enable one to disconnect or breakthe cable at the fastening means to manually operate the height of thereservoir bag or otherwise disconnect the automatic regulation of thereservoir height. Control means 1130 may be housed inside the cartapparatus 1105 in a compact manner. A handle 1140 adds portability tothe cart.

The following method steps illustrate in basic form how to set-up anduse the tubing set of a preferred embodiment of the present invention asit relates to the processor based embodiments:

1. Place the spiker assembly(s) of the inflow line into thecorresponding positions on the shelf(s).

2. Place the pump tubing through the pump head.

3. Snap the accumulator module to the housing of the AC2000, and connectthe entry and exit ports with the tubing from the pump and to thepatient.

4. Connect the ports leading to and from the inflow manifold with thetubing from each auto-spiker tubing set assembly being used for thecase.

5. Attach suction lines to appropriate waste canisters.

6. If applicable, connect appropriate line to the floor and drape wastefluid collection device.

7. Attach the appropriate tube lines to the shaver or other suctionrelated instrument, the outflow cannula and, if applicable, the drape'sfluid collection pouch.

8. Prime--inflow line, pressure sense line and pressure compensationline.

9. Surgeon to insert 18 gauge needle (pressure sensing probe) into anunobstructed area of the joint/cavity.

10. Connect inflow line to inflow cannula and pressure sense line to 18gauge needle.

11. Surgeon sets pressure and flowrate.

12. Press "Run/Pause" to start flowing to begin surgery.

A more detailed set-up and operation instruction manual for a preferredembodiment of the present invention of FIG. 2 (the AC2000) is attachedhereto and forms a part of the present description of the invention as"Appendix A".

Turning attention now to certain particular operations using the AC2000,the general operating parameters for the system will be described forseveral typical procedures during arthroscopic surgery, such as theoperations "lavage", "clear view", "prime", "drain", "burr","pause/run", "flow", "auto pressure", "set pressure", and "set flowrates" shown in FIG. 6.

For instance, when the "clear view" function button 313, is depressed,the system provides a sequence of flow rates and pressures that attemptto clear the view (as seen through an illuminated endoscope) of debris,typically by raising the pressure from whatever baseline pressure hasbeen set, to dilate blood vessels within the body cavity and stop anyblood flow, and increasing the flow rates from whatever baseline flowrate has been set. Typically this procedure is set for a two minutecycle (the time of the cycle may be adjusted for more or less than thisnumber) where flow rates are increased 20% from baseline rates andpressure is increased 20% from baseline pressure. The "clear view"button 313 may be re-pressed prior to the completion of the cycle toreturn the AC2000 to its prior settings. Built in safety featuresprevent the AC2000 from exceeding certain safety limits with respect topressure limits. A status light on the console indicates the functionhas been selected.

Regarding the "burr/shaver" button 314, when this function is selectedthe AC2000 provides the optimal inflow and suction flow rates to bettermaintain distention of the body cavity (typically a knee or shoulderjoint), minimize viewing turbulence and fluid consumption during burringand shaving, which are performed by specialized tools that may beattached to the second shaver suction line 69 as shown in FIG. 1. Aslightly different flow rate between "burr" and "shaver" applies, withpressure and flow rates for "shaver" being slightly greater than for"burr", but the functions are otherwise identical. When this button isdepressed the processor of the AC2000 knows to activate the secondsuction discharge conduit 69.

Regarding the "lavage" function button 312, this function increases andthen decreases the pressure and flow rates for a predetermined period oftime over a cycle. Typically the fluid cycle is factory set for anincrease of 25% in baseline pressure and flow rates for 10 secondsfollowed by a decrease to 75% of baseline pressures and flow rates for10 seconds.

Regarding the "pause"/"run" and drain functions, buttons 317 and 311 inFIG. 6, these functions are related to the general operation of thesystem. For instance, "pause" will halt the operation of the AC2000 fora predetermined period of time and then resuming at the previous levelsof flow rate, pressure and other state parameters of the system; runwill negate the "pause" button and otherwise will start an operationthat is suspended; "drain" will drain the fluid from inside the bodycavity by halting the flow along the inflow supply line and opening theR and/or T valves controlling the waste discharge conduits to drainfluid from the body cavity. The "drain" function lasts until such timethat the operator depresses the "drain" button again, stopping theprocedure.

Likewise, the "flow" and "pressure" buttons 302 and 304 may be manuallyselected to a particular predetermined baseline that the processor willattempt to smoothly track the system to follow (subject to any safetyoverrides as described herein). For example, in a preferred embodimentthe flow rates (which typically can be set to range from 0-2000 ml/min)may be set to four predetermined rates, in descending order, such as"max.", "high", "mid" and "low". In a preferred embodiment of theAC2000, the "max." flow rate is 1200-2000 ml/min., the "high" flow rateis 750-1200 m/min., the "mid" flow rate is 300-750 ml/min., and the"low" flow rate is 0-300 ml/min.

Indicator lights may display which level has been selected. Pressure canalso be manually set to a baseline pressure, in either feet of water ormm-Hg, with a bar graph display and visual gauge for both the actual anddesired pressure values. Typically the present invention produces arange of pressures inside the body cavity 52 ranges between 10-150 (6.7ft-wc), while the pressure inside the supply conduit 48, owing topressure losses, is from between that pressure range found insidebetween the body cavity to up to 500 mm-Hg upstream of the body cavity.Likewise the range of vacuum produced inside the body cavity 52 by thevacuum fluid circuit ranges from up to 150 mm-Hg, while the vacuumproduced in the discharge lines 68, 69, owing to vacuum pressure losses,is higher and from up to 150 mm-Hg in or near the body cavity to between220-350 mm-Hg vacuum further downstream of the body cavity. However,greater or different pressure and vacuum values are possible within thebody cavity and fluid conduits without departing from the scope of theinvention. Differences in tolerance between desired pressure and actualpressure are preferably limited by the processor control system to about±10 mm-Hg.

The processor of the present invention is software driven, with thesoftware designed to anticipate likely flow rates, pressures, emergencyconditions and other parameters as taught and disclosed herein to givestable output and prevent surges or unnecessary interruptions of thesystem. For example, in response to a line being kinked which wouldindicate a blockage, the AC2000 automatically suspends operation bygoing into the "pause" mode, and indicates that such a blockage isdetected. Furthermore, the processor may be equipped with a table thatwill list indeterminate and unacceptable levels of pressure and flowrates, and either default to more acceptable levels and/or indicate ananomalous condition. With respect to all functions on the console theprocessor of the AC 2000 may employ algorithms to achieve a smooth,uniform tracking and performance to prevent unnecessary flow surges andoverpressure or underpressure states. The processor is responsible forthe numerous safety features that may be incorporated in the AC2000,such as responding to shut down or to place the system in a differentstate in response to such as indications out of flow in the supplyconduit, no flow or lack of flow in the discharge conduits, overpressureor underpressure, blockage of the conduits, waste canister overflow,backflow, spiker arming, pressure and vacuum pump state, pressureaccumulator and vacuum tank state, type of surgical procedure and othervalues that are taught or suggested by the present invention. Typicallythe processor samples the various major components of the AC2000 fivetimes a second, though a different sampling rate may be chosen.

Although several preferred embodiments of this invention have beendescribed in detail herein with reference to the accompanying drawings,it is to be understood that the invention is not limited to theseprecise embodiments, and that various changes and modifications may beaffected therein by one skilled in the art without departing from thescope or spirit of the invention. Accordingly it is to be understoodthat while the invention has been described above in conjunction withpreferred specific embodiments, the description and examples areintended to illustrate and not limit the scope of the invention, whichis defined by the scope of the appended claims.

We claim:
 1. A fluid management system for irrigation of a body cavity comprising:a reservoir of fluid suspended a height "h" above the body cavity, said reservoir containing a fluid discharge conduit leading from said reservoir to the body cavity, with said reservoir providing fluid under pressure to said body cavity in accordance to the height "h" in gravitational head; means for raising and lowering said reservoir of fluid to vary said gravitational head of pressurized fluid to said body cavity; control means to control said means for raising and lowering said reservoir of fluid; wherein said control means are processor based and further comprising means to sense pressure inside said body cavity, said control means controlling said means for raising and lowering said reservoir of fluid to vary the height "h" in response to said means to sense pressure.
 2. A fluid management system for irrigation of a body cavity comprising:a reservoir of fluid suspended a height "h" above the body cavity, said reservoir containing a fluid discharge conduit leading from said reservoir to the body cavity, with said reservoir providing fluid under pressure to said body cavity in accordance to the height "h" in gravitational head; means for raising and lowering said reservoir of fluid to vary said gravitational head of pressurized fluid to said body cavity, wherein said means for raising and lowering said reservoir of fluid comprises a winch attached to a cable, a pulley, and an arm holding said pulley, said cable attached to said reservoir of fluid and disposed about said pulley, and a motor controlling the winding and unwinding of said winch.
 3. The invention according to claim 2, wherein said means to control said means for raising and lowering control the powering on and off of said motor.
 4. A portable fluid management system for irrigation of a body cavity comprising:a cart having wheels and at least one vertically extending arm; a pulley mounted on said arm, said pulley guiding a cable; a reservoir of fluid attached to said cable, said reservoir having a fluid discharge conduit leading from said reservoir to withdraw fluid from said reservoir to a body cavity; a winch driven by a motor for reeling in said cable, wherein the length of the cable determines the height said reservoir is raised above ground and the amount of gravitational head pressure supplied by said reservoir; means to control said winch; and means to sense the pressure in said body cavity, wherein said control means in response to said pressure sensing means may drive said winch to adjust the height of said reservoir.
 5. The invention according to claim 4, wherein said arm is telescoping, said control means comprises a processor that is voice activated, and further comprising fastening means on said cable to disconnect said cable from attachment to said winch.
 6. The invention according to claim 4, wherein pulley is supported by two arms, said arms being telescoping, and wherein said control means, said winch and said motor are housed inside said cart.
 7. In an improved fluid management system for irrigation of a body cavity comprising:a supply of irrigation fluid; an accumulator, mounted on a post, for receiving said irrigation fluid; means for sensing the amount of fluid in said accumulator, said sensing means mounted on said post; means for pumping said irrigation fluid from said irrigation fluid supply to said accumulator; a supply conduit connecting said accumulator to a body cavity for irrigation of said body cavity; control means for sensing said means for sensing the amount of fluid in said accumulator to control the pumping of said pumping means; wherein said accumulator is kept full by said control means to provide a reservoir of fluid, wherein:said control means further comprises a count-down timer set to count down time from a predetermined time, and actuated to start counting down when said pumping means are powered on to pump irrigation fluid to said accumulator in response to said sensing means; said count-down timer reset to said predetermined time when said pumping means are powered off to stop pumping irrigation fluid in response to said sensing means; means for producing an alarm in response to said count-down timer, wherein said count-down timer produces a signal to activate said alarm means when said count-down timer reaches zero.
 8. The invention according to claim 7, further comprising:a unit housing said alarm means and said post, said unit having a clamp for attachment to an I.V. pole; said pumping means is a peristaltic pump; said sensing means is a sensor to sense the weight of fluid in said reservoir, said reservoir hanging from a cantilevered arm attached to said post. 